BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 18369406 · Received December 20, 2023

    Report

    Report Number
    1710034-2023-01463
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Date of Event
    November 27, 2023
    Report Date
    March 6, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825332
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ITEM # 1612-53320 BD IV CATH, 20 GA 1" BLOOD CONTROL (BECTON DICKINSON # 382533). OUR CUSTOMER, AREA AMBULANCE, HAS REPORTED ¿LOT # 3192270 EXPERIENCED A DELAY WHEN THE PUSH BUTTON WAS ACTIVATED. CUSTOMER JUST RECEIVED. 8 CASES TODAY. CUSTOMER PULLED SAMPLES FOR SEVERAL BOXES AND EXPERIENCED THE SAME DELAY. THIS DOES NOT HAPPEN ON ALL. THIS LOT NUMBER IS 3192173 FOR ALL 8 CASES.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297874 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192270 00382903825332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown